Treats symptomatic obstructive hypertrophic cardiomyopathy (oHCM). NDA 219083, held by Cytokinetics. Aficamten.
As of Nov 13, 2026, NDA 219083 (Myqorzo), held by Cytokinetics, was first approved by FDA on Dec 19, 2025, with 1 approved supplement and 0 published complete response letters.
MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2025 | Original applicationNew molecular entity · Standard review | Approved |
| Feb 5, 2026 | Supplement 1REMS | Approved | |
| Dec 19, 2025 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
